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临床试验/NCT06441305
NCT06441305招募中不适用

Assessing the Impact, Implementation and Cost of Empowering Community Health Promoters to Improve Wasting Treatment Coverage in Turkana County Through Family-led MUAC Scale-up, Weight-for-age Screening, and Defaulters' Follow-up

International Food Policy Research Institute1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2024年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,600
试验地点
1
主要终点
Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age

研究概览

简要总结

Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment.

In Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues.

The study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up.

In addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.

详细描述

Despite the burden and impact of child wasting on morbidity and mortality, only a small proportion of severely wasted children are presently receiving treatment. In Kenya, there is an opportunity to strengthen the screening for wasting and the identification and treatment of wasted children (SWITCH) through community health promoters (CHPs) who, per policy, are trained, equipped, incentivized and supervised by community health agents (CHAs).

An intervention package will be implemented including: 1) Digitization to support CHPs, 2) Family-led Mid-Upper Arm Circumference (MUAC) enhanced by digitization, with a two-way messaging platform between CHP and caregivers, and reminders for timely training at 6 months of age, 3) Equipment of CHPs with a baby-mother scale for measurement of weight-for-age to detect likely wasting, and 4) Real-time follow-up in the community (facilitated by digitization) of defaulters and non-respondent children enrolled for wasting treatment.

A randomized controlled trial will be used to assess the impact of the SWITCH intervention on severe wasting treatment coverage in Turkana. Twenty randomly selected community units of 40 will receive the intervention. An exhaustive screening campaign conducted at baseline and endline (after 2 years) in the 40 community units will identify children with severe wasting (MUAC < 115 mm or Weight-for-Height Z-score < -3 or bilateral pitting oedema) or recovering from severe wasting (defined by receipt and consumption of Ready-to-Use Therapeutic Food), who will be enrolled in a survey assessing treatment coverage, program exposure and other pathways to impact, and confounders.

In addition, the study will assess the reach, adoption by CHPs, and implementation challenges of the SWITCH package through additional qualitative (interviews and observations) and quantitative data collection at all levels of program delivery (beneficiaries, CHPs, CHAs, program implementers); and the unit cost of the SWITCH package per beneficiary (and cost-effectiveness if the package is effective) through an activity-based costing-ingredients approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Evaluator teams will be blinded from intervention allocation

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Household in a village of the study area covered by a CHP (although the child may or may not be registered by a CHP) AND
  • Child is 6-59.9 months of age AND
  • Caregiver consents to be part of the study AND
  • any of the following:
  • WHZ < -3 (relative to WHO 2006 reference) OR
  • MUAC <115 mm OR
  • Presence of bilateral edema OR
  • receiving treatment as follow-up for an initial SAM condition on the way to full recovery

排除标准

  • Congenital malformation that makes anthropometric measurements impossible.
  • Length is below 54 cm or height is above 120cm.

研究组 & 干预措施

Standard of Care

No Intervention
  • Register-based household registration (census) by CHP every 12 months
  • Some family MUAC of variable and unknown coverage/frequency, national guidance developed.
  • Some passive screening using weight-for-height z-score at Health Facility and during outreach during Malezi bora (child health week every 6 months).
  • Monthly compilation by CHA (supervisors) of the list of defaulters and non-respondents for transmission to relevant community health promoter (CHP) during monthly in-person meeting.

SWITCH intervention package

Experimental
  • Addition of digital monitoring & supervision by CHA
  • Digitized registration of households by CHPs every 6 months
  • Digital reminders to CHP to conduct home visit if a child has never been visited in 3 mo.
  • Digital reminder for timely training to family MUAC of all family members through home visit by CHP when child turns 6 months of age.
  • Platform for 2-ways messaging: biweekly SMS reminders to caregivers through the CHP's app; feedback by caregiver
  • Community level screening based on weight and weight-for-age (WAZ) led by CHP every other month (aligned with Community Action Days),
  • Digital calculation of WAZ.
  • CHP and Growth Monitoring and Promotion refer to health facility if WAZ<-3 to check on WHZ eligibility
  • At the end of every wasting treatment consultation, compilation of the list of defaulters and non-respondents, for immediate transmission by CHA to relevant CHP through digital task of an instruction for immediate follow-up.

干预措施: SWITCH intervention package (Behavioral)

结局指标

主要结局

Period prevalence of severe wasting (SAM) treatment coverage in children 6-59 months of age

时间窗: After 24 months of program implementation

defined as the proportion of children suffering from SAM or recovering from SAM who currently receive treatment. • SAM defined by weight-for-height Z-score (WHZ) \<-3 (relative to World Health Organization (WHO) 2006 reference) or MUAC \<115 mm or by the presence of bilateral edema. Children recovering from SAM through treatment will be considered to receive treatment for an initial SAM condition if they both attended an IMAM consultation in the previous 15 days (as reported by caregiver OR by a consultation card) AND either: * consumed RUTF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation of \>= 1 full or 2 empty RUTF sachets) OR * consumed RUSF at least once in the previous 3 days (as reported by the caregiver AND confirmed by observation by the enumerator of \>= 1 full or 2 empty RUSF sachets) AND child was previously enrolled for SAM treatment immediately prior to MAM treatment (as confirmed by treatment card OR reported by the mother

次要结局

  • Prevalence of very low MUAC(After 24 months of program implementation)
  • Prevalence of appropriate immunization(After 24 months of program implementation)
  • Coverage of WAZ screening(After 24 months of program implementation)
  • Point prevalence of SAM outpatient therapeutic program (OTP) treatment coverage in children 6-59 months of age(After 24 months of program implementation)
  • Screening coverage of SAM(After 24 months of program implementation)
  • Prevalence of very low WHZ(After 24 months of program implementation)
  • Mean height-for-age Z-score (HAZ)(After 24 months of program implementation)
  • Mean mid-upper arm circumference (MUAC)(After 24 months of program implementation)
  • Prevalence of underweight and severe underweight(After 24 months of program implementation)
  • Mean weight-for-height Z-score (WHZ)(After 24 months of program implementation)
  • Coverage of MUAC tapes(After 24 months of program implementation)
  • Prevalence of stunting(After 24 months of program implementation)
  • Caregiver's knowledge score(After 24 months of program implementation)
  • Coverage of the community unit platform(After 24 months of program implementation)
  • Coverage of the integrated management of acute malnutrition (IMAM) platform(After 24 months of program implementation)
  • Coverage of family MUAC(After 24 months of program implementation)
  • Coverage of family MUAC training(After 24 months of program implementation)
  • Mean longitudinal prevalence of child morbidity(After 24 months of program implementation)
  • Prevalence of SAM(After 24 months of program implementation)
  • Prevalence of moderate acute malnutrition (MAM)(After 24 months of program implementation)
  • Prevalence of wasting(After 24 months of program implementation)
  • Mean weight-for-age Z-score (WAZ)(After 24 months of program implementation)
  • Period prevalence of wasting treatment coverage in children 6-59 months of age(After 24 months of program implementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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